Senior Clinical Data Management Expert
1 day ago
Company Overview
Excelya, a leading CRO in Europe, offers a unique opportunity to collaborate with a Full Service Provider Senior Clinical Data Manager (Sr CDM) role based in Bangalore, India. Our global team of 900+ experts provides trial solutions across various therapeutic areas, taking a one-team approach to work and encouraging personal, intellectual, and operational participation.
Job Description
We are looking for an experienced Senior Clinical Data Manager to perform data management tasks per client work orders to high regulatory standards and Client SOPs. This includes data cleaning, review, discrepancy management, and reconciliation activities on assigned studies. The successful candidate will work closely with the Lead Data Manager responsible for the study, generate study metrics and status reports, and participate in EDC database build and testing through go live.
Key Responsibilities
- Deeply acknowledges and strictly follows applicable Excelya and Client's SOPs.
- Responsible for data cleaning, data review, discrepancy management and data reconciliation activities on the studies assigned.
- Work closely with the Lead Data Manager responsible for the study.
- Generate study metrics and status reports within and across several studies.
- Participate to study documentation archiving.
- Participate in EDC database build and testing through go live.
- May act as a Lead Data Manager on simple studies.
- Provides oversight for more junior staff.
- Complete Excelya administrative tasks as required e.g., timesheets, CV and training updates.
Requirements
- Holds a Bachelor's degree qualification in a Scientific discipline is preferred.
- Five or more years as a Data Manager or equivalent combination of education, training and experience.
- Knowledge and understanding of ICH GCP and other relevant ICH, EU or FDA guidelines to maintain regulatory compliance.
- Understanding of recommended CDM best practices and associated documentation.
- Experience in clinical trial databases and applications, clinical data flow, data review, and eCase Report Form design.
- Understanding of clinical trials and study lifecycle (start-up, maintenance & closeout).
- Proficient in computer technology used in an office environment (Word, Excel, PowerPoint, MS Project, etc.).
- Ability to maintains high level of professionalism, ethics and compliance at all times.
- Effective verbal and written communication skills.
- Fluent in local language and English (written and verbal).
Estimated Salary: ₹1,200,000 - ₹1,800,000 per annum
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